NCT03930563

Brief Summary

The main purpose of this study is to determine if acute beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. All subjects will consume low-dose (BRL), higher-dose (BRH), and placebo (BRP) beetroot juice randomly on three independent study visits. Beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

April 19, 2019

Last Update Submit

April 26, 2021

Conditions

Obstructive Sleep Apnea

Keywords

inorganic nitrateblood flowPeripheral chemoreflexCommon carotid artery

Outcome Measures

Primary Outcomes (1)

  • Changes in peripheral chemoreflex sensitivity

    The ventilatory response to acute hypoxia will be measured via pneumotachometer.

    Before and after consuming all supplements (within three hours)

Secondary Outcomes (1)

  • Changes in common carotid artery blood flow

    Before and after consuming all supplements (within three hours)

Study Arms (3)

Beetroot Juice Low

EXPERIMENTAL

Subjects will consume beetroot juice containing 250mg inorganic nitrate and 20mg nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.

Dietary Supplement: Pre-beetroot juice supplementationDietary Supplement: Post-beetroot juice supplementation

Beetroot Juice High

EXPERIMENTAL

Subjects will consume beetroot juice containing 500mg inorganic nitrate and 40mg nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.

Dietary Supplement: Pre-beetroot juice supplementationDietary Supplement: Post-beetroot juice supplementation

Beetroot Juice Placebo

ACTIVE COMPARATOR

Subjects will consume beetroot juice devoid of inorganic nitrate and nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.

Dietary Supplement: Pre-beetroot juice supplementationDietary Supplement: Post-beetroot juice supplementation

Interventions

Pre-beetroot juice supplementationDIETARY_SUPPLEMENT

Before administering beetroot juice to subjects.

Beetroot Juice HighBeetroot Juice LowBeetroot Juice Placebo
Post-beetroot juice supplementationDIETARY_SUPPLEMENT

After administering beetroot juice to subjects.

Beetroot Juice HighBeetroot Juice LowBeetroot Juice Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSA group: patients recently diagnosed with mild-to-moderate OSA
  • Control group: healthy individuals

You may not qualify if:

  • Diagnosis of heart disease
  • Diagnosis of diabetes
  • Diagnosis of any autonomic disorders
  • Diagnosis of kidney disease
  • Diagnosis of central sleep apnea
  • Regular physical activity exceeding 30 minutes 3 days/week
  • A body mass index ≥40 kg/m2
  • Current or former use of a continuous positive airway pressure machine
  • Current tobacco use
  • Currently prescribed hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Education Building

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Darren P Casey, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 29, 2019

Study Start

June 12, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)